BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3405346 · Received October 10, 2013

    Report

    Report Number
    9611451-2013-00794
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PS138791. THE RT105 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. LOT & DATE OF MANUFACTURE INFORMATION OF THE RETURNED RT105 BREATHING CIRCUITS: OPENED DEVICES RECEIVED: 1 X RT105 LOT:130522; 1 X RT105 LOT: UNKNOWN. UNOPENED DEVICES RECEIVED: 8 X RT105 LOT:130522; 3 X RT105 LOT: 130515. METHOD: A TOTAL OF 13 RT105 ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. OF THESE 13, TWO WERE OPENED AND 11 WERE UNOPENED. THE TWO OPENED DEVICES, TWO SEALED RT105 CIRCUITS FROM LOT 130515 AND TWO SEALED RT105 CIRCUITS FROM LOT 130522 WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: PRESSURE TEST REVEALED THAT ALL OF THE EXAMINED BREATHING CIRCUITS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAKS WERE THROUGH THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAPS. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130515 AND NO COMPLAINTS FOR LOT 130522. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT ANY LEAK MUST HAVE DEVELOPED AFTER THE BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT105 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: - "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "SET APPROPRIATE VENTILATOR ALARMS." THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE LEAKS ON THE COMPLAINT DEVICES DURING A SETUP CHECK BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    HOLD - SDAA HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT SOME RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A SERVO VENTILATOR. THESE WERE FOUND DURING THE SETUP CHECK AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516005 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT105 130515, 130522

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR